Upper airway resistance to airflow afflicts millions of individuals and can have very serious medical consequences including significant morbidity and mortality. The health effects are brought about by the disruption of normal sleep with snoring and sleep apnea (i.e. a complete stoppage of breathing for a period of time). The effects of snoring and sleep apnea may also compromise the well being of those sleeping in proximity to the afflicted person by disrupting their ability to achieve healthy, restful sleep.
Sleep is impacted by both the increased effort needed to overcome increased resistance to airflow and by the fragmentation of sleep patterns brought about by awakenings that occur in both hyponia (i.e. reduced air flow) and apneic events (i.e. periods of stoppage of air flow). These conditions limit one's ability to enter deeper stages of sleep that are necessary to refresh and restore and are damaging to many body systems.
The primary treatment for snoring and apnea is the use of a device, referred to as a continuous positive air pressure (CPAP) device. The CPAP device delivers pressurized air from a pumping component through a hose to a mask which is secured over the nose of the individual. The CPAP device can be successful at correcting the problem but it is not well tolerated by a significant group of individuals due to discomfort and lifestyle issues, and due to the lack of portability of the CPAP device. Because of these factors a significant number of patients are forced to abandon the use of this therapy.
Surgical techniques that attempt to permanently correct snoring problems encountered by individuals have been available for many years. However, surgical techniques are complicated and invasive and sometimes permanently change the appearance of the individual. In addition, numerous medical drawbacks are inherent in surgical procedures, including cost, irreversibility, surgical risk, and long painful recovery periods.
Numerous alternative devices have been developed which attempt to alleviate or eliminate snoring problems without invasive surgery. Some devices have focused on improving airflow through the nose. These devices are used both in awake periods, during increased demand such as athletic usage, and during sleep to improve airflow as an anti-snoring device. One such device, taught in U.S. Pat. No. 6,375,667 to Ruch, attaches to the external skin along the right and left sides of the nose by means of adhesives. The device is spring biased and pulls the skin outward to strengthen and expand the nasal passages. However, the device of Ruh '667 is disposable and the adhesives can irritate the skin. Another device, taught in U.S. Pat. No. 5,727,543 to Corsaro, is designed to fit inside the nasal airway and push the inner walls of the nose out, expanding the air passage. The device of Corsaro '543 can irritate the sensitive inner lining of the mucosa of the nasal airway and is awkward to use.
Other devices have been developed which attempt to alleviate or eliminate snoring problems without invasive surgery by repositioning the lower jaw (mandible) in an anterior (forward) direction. The repositioning pulls the base of the tongue forward, thereby increasing the air passage in the posterior pharyngeal region (i.e. the breathing passage behind the base of the tongue). Devices which bring the mandible forward into a functional repositioning posture, and which hold the posterior airway open can be adjustable or non-adjustable. A non-adjustable device fits in the mouth at a prescribed position. The disadvantage of this is that there are changes that occur over time which require the position of the mandible in relationship to the maxilla to be changed. Available adjustable devices arrange significant components inside the mouth behind the teeth. These components take up space inside the mouth, restricting the space for the tongue and preventing the tongue from coming forward. Some devices also have projections which extend from the mouth out between the lips. These affect the user's ability to close their lips, making the appliance less comfortable and inhibiting the ability of the user to turn to different positions during sleep.
Simpler devices have recently been developed to treat sleep apnea. One such device is THE FULL BREATH SOLUTION®, developed by the Full Breath Corporation of Tarzana, Calif., which prevents blockage of the throat by the tongue by holding the base of the tongue down and forward. However, such devices rely on materials positioned at the back of the throat which can cause gagging.
There is a need for devices and techniques to improve airflow in nasal-pharyngeal airways that reduce or eliminate the disadvantages of available treatments.